Isolated gene sequences are patentable in Australia

In a decision handed down on Friday 5 September 2014 a Full Federal Court consisting of 5 Justices affirmed the decision of Nicholas J at first instance that isolated DNA and RNA are patentable subject matter.

The issue was whether a patent may be granted for a claim that covers naturally occurring nucleic acid that has been isolated from all cellular components. The patent in question covered the isolated BRCA1 gene and its breast and ovarian cancer promoting mutations. It was challenged solely on the basis that the claims are not for a manner of manufacture, as required by Australian law. The appellants submitted that isolated nucleic acid is no different to cellular nucleic acid, and that naturally occurring DNA and RNA, even in isolated form, are products of nature that cannot form the basis of a valid patent.

Section 18(1)(a) of the Patents Act 1990 requires that the claimed invention must be a “manner of manufacture” within the meaning of section 6 of the Statute of Monopolies in order to constitute patentable subject matter. Nicholas J found at first instance, applying the broad construction given to the term “manner of manufacture” by the High Court in National Research and Development Corporation v Commissioner of Patents (NRDC case) that each of the challenged claims were to an artificially created state of affairs with economic utility. Nicholas J differentiated between nucleic acid as it is found inside the cell, and its form when isolated.

The Full Federal Court applying the NRDC case principles affirmed the decision of Nicholas J. Both Nicholas J and the Full Court made it clear that DNA and RNA that occur naturally inside the cells of the human body cannot be the subject of a valid patent. However, they also concluded that the isolated nucleic acid itself was the claimed product and that is different to the DNA and RNA as it exists in nature – there are structural differences, and, more importantly, functional differences as a result of the isolation. The Full Court emphasised that it is these changes in the isolated nucleic acid that are of critical importance, as this is what distinguishes the product from the naturally occurring nucleic acid as artificial and economically useful.

This conclusion contrasts with the U.S Supreme Court findings in Association for Molecular Pathology v Myriad Genetics Inc, where it was held that a naturally occurring DNA segment is a product of nature and is therefore not patentable, even if isolated. The reasoning in this case however focused on the information contained in the nucleic acid sequence, rather than the product itself.

This decision may be the subject of an application for special leave to appeal to the High Court. However, it seems unlikely that the issue will be the subject of legislative intervention given that Parliament has considered, and has specifically declined, to exclude purified and isolated gene sequences from the scope of patentable subject matter.